Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients

Summary

Myeloproliferative neoplasms (MPNs) are blood disorders that occur when the body makes too many white or red blood cells, or platelets. This overproduction of blood cells in the bone marrow can create problems for blood flow and lead to various symptoms. One of the major problems is the formation of blood clots. These may form in the veins of a patient's legs or arms where they cause leg or arm pain, swelling or difficulty walking. These clots may travel to the lung and then cause chest pain, shortness of breath and sometimes death. Blood clots can also lead to poor or no blood flow to one's heart, brain, or other organs, causing damages that cannot be easily or ever repaired, such as stroke or heart attack.

Patients diagnosed with certain types of MPN are associated with a higher risk of developing blood clots and related complications. For this reason, MPN patients are usually treated with low-dose aspirin, a common drug used for blood clot prevention, on long-term basis to prevent the formation of blood clots and other complications. However, recent studies also show that the risk of blood clots remains elevated in MPN patients treated with aspirin, and there may not be improvement or reduction in fatal or other events that are associated with blood clots. In addition, since this medical condition is rare, so there's a lack of studies done with high quality results to help physicians decide the best treatment plan for these patients.

The study drug, apixaban, is a new type of orally-taken blood thinner that has been shown to be effective and safe for prevention and treatment of blood clots in various patient populations. The investigators will evaluate whether apixaban is safer and/or better at preventing blood clots and other complications in MPN patients compared to aspirin.

Conditions

• Myeloproliferative Neoplasm (MPN)
• Essential Thrombocythemia (ET)
• JAK2 Mutation
• Polycythemia Vera (PV)
• Primary Myelofibrosis
• Venous Thromboembolism (VTE)

Interventions

DRUG

Apixaban 2.5 MG Oral Tablet [ELIQUIS]

2.5mg twice per day for 6 months Then treated \& followed up as per standard of care

DRUG

Aspirin 81 mg

81mg once per day for 6 months Then treated \& followed up as per standard of care

Sponsors & Collaborators

• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

  collaborator NETWORK

• the Association médicale universitaire de l'Hôpital Montfort (AMUHM)

  collaborator UNKNOWN

• Canadian Hematology Society

  collaborator UNKNOWN

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Aurelien Delluc, MD, PhD · The Ottawa Hospital

• Miriam Kimpton, MD · The Ottawa Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-17

Primary Completion

2023-10-31

Completion

2024-05-03

Countries

• Canada

Study Locations